Bioequivalence and Bioavailability Forum • Wow, Wow ...

Wow, Wow ... [🇷 for BE/BA]

posted by d_labes – Berlin, Germany, 2011-01-21 15:43 (5263 d 08:11 ago) – Posting: # 6474
Views: 30,771

Dear Helmut,

beyond belief for me simple minded but seems definitely TRUE.

Have a look at Figs. 3 and 4 of
Haidar et. al.
Evaluation of a Scaling Approach for the Bioequivalence of Highly Variable Drugs
The AAPS Journal, Vol. 10, No. 3, p450-454, 2008
online resource
to see the same behaviour, also for the combined criteria scaled ABE + constraint on point estimate.

See also
Endrenyi, Tothfalusi
Presentation at BASS 2010
Scaled Average bioequivalence: An Approach to Resolve a Difficult Program
page 21-23.

See also Page 28 of that presentation to notice increasing power after CV=30% if point estimator is 1.1, same as we have had here for point estimator = 0.95.
It would be interesting to know how good the real values of the simulated power are in accordance with our naive power calculations, not only the qualitative behaviour.

Seems I had read all this stuff, but never had this figured out well.
What we here see is the mean vs. variance trade-off in the scaled ABE evaluation. Greater differences in the means µ_T-µ_R are allowed with increasing variability to have the same value for the scaled ABE criterion.
Eventually this is one of the sources for introducing the GMR constraint?

—
Regards,

Detlew

Complete thread:

Feature suggestion for bear and PowerTOST ElMaestro 2011-01-16 19:13
- Sample size for widened scaled ABE limits d_labes 2011-01-17 13:19
  - 0.760 or... Helmut 2011-01-17 14:38
    - ... full precision is the question d_labes 2011-01-17 16:37
      - ... full precision is the question Helmut 2011-01-17 18:06
        
        OT: Number of horns on a unicorn d_labes 2011-01-18 08:32
        
        Goooogle Helmut 2011-01-18 11:44
  - Cadmium ElMaestro 2011-01-19 17:50
    - Never eaten Cadmium deliberately d_labes 2011-01-20 15:00
      - Never eaten Cadmium deliberately Helmut 2011-01-20 15:25
        
        Call of duty for simulants d_labes 2011-01-20 16:15
        
        Counterinuitive Helmut 2011-01-21 04:13
        
        Counterintuitive d_labes 2011-01-21 08:36
        
        Counterintuitive Helmut 2011-01-21 12:53
        
        Counterinuitive, but ... d_labes 2011-01-21 12:12
        
        Counterinuitive, but ... Helmut 2011-01-21 13:01
        
        Wow, Wow ...d_labes 2011-01-21 14:43
        
        Never eaten Cadmium deliberately ElMaestro 2011-01-21 12:59
        
        Simulants of the world, unite! Helmut 2011-01-21 14:05
        
        Simulants of the world, unite! ElMaestro 2011-01-21 14:52
        
        Hyslop, Howe, scaled ABE and that all d_labes 2011-01-21 15:28
        
        Hyslop, Howe, scaled ABE and that all ElMaestro 2011-01-21 15:45
        
        scABE and missings d_labes 2011-01-21 16:19
        
        Intuition Helmut 2011-01-21 18:41
      - Never eaten Cadmium deliberately ElMaestro 2011-01-20 15:34
        
        Use of Cadmium d_labes 2011-01-20 16:06
        
        Use of Cadmium ElMaestro 2011-01-20 16:52
        Use of Cadmium ElMaestro 2011-01-20 17:53